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A woman receives an infusion of donanemab, part of a new class of disease-modifying drugs used to treat early Alzheimer’s.Jens Kalaene/Reuters
Canada’s Drug Agency is recommending that a second disease-modifying medication used to treat people with early Alzheimer’s disease should be publicly covered, with conditions.
The agency, which offers non-binding recommendations for drug reimbursement through its expert committee, released draft recommendations on the medication donanemab on Thursday.
In a report, the Canadian Drug Expert Committee found donanemab provided clinical benefits by “slowing cognitive and functional decline.”
Alzheimer’s, a progressive and irreversible disease, is characterized by worsening cognitive decline and functional impairment. It is the most common cause of dementia. As of January, 2025, it was estimated 771,939 people in Canada live with dementia.
The drug expert committee’s recommendation, supported by 11 of its members while three voted against, sets the stage for possible public funding of the medication, not currently captured by provincial or territorial drug plans.
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The medication carries a costly sticker price: $47,250 annually, per patient.
The majority recommended there be conditions for public coverage, including limiting it to adult patients who are 50 and older with a clinical diagnosis of mild cognitive impairment or mild dementia owing to Alzheimer’s disease.
As well, patients must not be homozygous for the APOE4 gene variant, which is the highest genetic risk factor for late-onset Alzheimer’s. It also said pricing must be significantly reduced before public reimbursement.
Donanemab, which is administered as an infusion therapy and marketed under the brand name Kisunla, is part of a new class of disease-modifying drugs used to treat early Alzheimer’s.
Previously, medications used to treat the disease could only address symptoms. However, new medication options are designed to target and clear beta-amyloid, a protein that turns into clumps in the brain, which sets off a series of events that leads to brain-cell death.
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Mathilde Merlet, president and general manager of Lilly Canada Inc., the pharmaceutical company that makes donanemab, applauded the committee’s positive recommendation.
She said it recognizes the importance of offering patients who are diagnosed with early symptomatic Alzheimer’s disease a treatment option, at a time when intervention matters.
“Timely intervention for patients with early symptomatic Alzheimer’s can have the greatest impact to slow the progression of this devastating disease,” she said in a statement.
Ms. Merlet said for more than 30 years, the company has led research to pursue a treatment for Alzheimer’s disease.
“Today, we celebrate a historic milestone,” she said. “We are committed to working with the government and broader healthcare ecosystem to accelerate access for eligible patients.”
The drug was approved by Health Canada in May, more than two years after the federal department responsible for regulating drugs began reviewing the medication in February, 2024.
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The Alzheimer Society of Canada said at that time it could still take more than a year to become accessible through private drug plans and more than two through public plans. It added that this underscores the importance of receiving a timely diagnosis because the medication is effective only for those in the earliest stages of the disease.
The society also pointed to World Alzheimer Report 2024, which found more than 90 per cent of respondents would pursue a dementia diagnosis if they knew a disease-modifying treatment was available.
Donanemab is one of two recently approved disease-modifying Alzheimer’s treatments in Canada; the other is lecanemab.
In July, the CDA reversed a previous recommendation and said public drug plans should cover lecanemab’s cost.
The expert committee’s report said lecanemab “may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value.”
Health Canada approved the medication last October. However, it also carries a high price tag. The annual cost of it is around $30,000.
Neither donanemab nor lecanemab are considered to be cures for Alzheimer’s disease. The medications are designed to slow cognitive decline to allow patients to stay in mild stages of the disease for longer.
With reports from Alanna Smith and Kelly Grant